Professional Documents
Culture Documents
Introduction
2
Introduction
Although the skill and technique of the surgeon is important, so is the choice of
wound closure material (Chu 1981, p.371). The purpose of these materials is to
maintain wound closure until a wound is strong enough to withstand daily tensile
forces and to enhance wound healing when the wound is most vulnerable (Giray
1995, p.44). A wound may be approximated with sutures, staples, clips, skin
closure strips, or topical adhesives.
Chu (1981, p.367) and Ogrady (1994, p.208) generally classified suture materials
which includes natural and synthetics, absorbable and nonabsorbable,
monofilament and multifilament. Natural materials are more traditional and still are
used in suturing today. Synthetics are less reactive in that the resultant
inflammatory reaction around the suture material is minimized.
Wound closure is a part of any surgical procedure. Wound care and healing
process are concepts, which are usually reliant upon sutures. The suture and non-
suture repair of the tissues has been a major concern to surgeons for over four
thousand years.
Though metal clips produce excellent cosmetic result they are to be removed within
48 to 72 hours, otherwise the local increased tension and ischemia produce ugly
and permanent cross-hatching and a poor cosmetic appearance (Ogrady et al.
1994, p.207).
Adhesive tapes designed to affect skin closure are mainly limited to small facial
wounds on the account of their size and adhesive properties (Elmasalme et al.
1995, p. 838).
From the past three decades, many new biomaterials have been discovered in the
medical field. Bio-adhesives are one among them. This material when applied on
the incised tissues possesses the ability to bind them together (Giray et al. 1997,
p.257). This group of adhesives called Cyanoacrylates were first described in 1949
by Adris (Quinn 1997, p.1527) and used clinically by Coover et al (1972, p.453) as
agents to glue skin wounds (Penoff et al. 1999, p.730). These glues polymerize on
contact with basic substances such as water or blood to form a strong bond (Burns
et al. 1998, p. 1069).
of needle stick injury. They also provide excellent waterproof wound protection,
which act as a protective dressing (Giray et al. 1997, p.257).Though tissue
adhesives have many advantages over conventional wound closure techniques,
they can be used as an alternative to sutures only in superficial small and tension
free skin incisions or lacerations (Qureshi et al. 1997, p.414).
The first glue developed was Methyl Cyanoacrylate, which was studied extensively
for its potential medical applications and was rejected due to its tissue toxicity.
Methyl alcohol, which has a short molecular chain, contributes to these
complications. Further research revealed that by changing the type of alcohol in the
compound to one with a larger molecular chain, the tissue toxicity was much
reduced. By increasing the size of the molecule it was possible to lengthen the time
taken to polymerize (Burns et al. 1998, p.1068).
The purpose of this study was to compare the healing and cosmetic outcome of
head and neck surgical incisions by using Polypropylene suture and N-Butyl-2-
cyanoacrylate.
6
Incision is a basic step for surgical procedures. Suitable closure and optimal
maintenance of the surgical area are the most important factors that affect proper
wound healing, surgical success and cosmetic outcomes.
The N-butyl-2-cyanoacrylate tissue adhesive in our country is usually not used and
the available data in our context is not available. Our study is to compare the mostly
used polypropylene suture material with this newer n-butyl-2-cyanoacrylate tissue
adhesive and serves to furnish few data that would contribute to better closure of
head and neck incision.
7
Specific:
Review of literature
9
Review of literature:
Mehta M.J, Shah K.H treated ten cases of mandibular fractures by using N-butyl-2-
cyanoacrylateand found that there was no mobility of the fractured bony segments
in nine cases. Toxicology study showed no significant change in the blood and
urine post-operatively. They preferred to use adhesives in treating mandibular
fractures instead of bone plates due to their case of application and bacteriostatic
property.
Forseth M, O’Grady K and Toriumi D.M (1992) reviewed the status of N-butyl-2-
cyanoacrylateand fibrin tissue adhesives. They stated that N-butyl-2-
cyanoacrylatehas excellent binding strength for skin closure. However its
subcutaneous implantation can result in inflammation and foreign body giant cell
reaction. Fibrin tissue adhesive demonstrated good hemostatic properties with low
binding strengths.
Farhan N. Elmasalme, Matbouli S.A and Zuberi M.S (1995) used N-butyl-2-
cyanoacrylatetissue adhesive in closing skin incisions of more than 3274 cases and
2650 small lacerations on scalp, face and limbs. They recommend using this tissue
adhesive due to its simplicity of application, low cost and high success rate with
only 0.83% failures.
Burns TB, Simon H.K, McLario D.J et al (1996) studied the effectiveness of N-butyl-
2-cyanoacrylateon lacerations in children and concluded that the use of tissue
12
Veloudios A, Kratky V, Heath Kote J.G et al (1996) studied the advantages of the
tissue adhesive N-butyl-2-cyanoacrylateand compared it with 6-0 nylon sutures for
closing bilateral upper and lower eye lid blepharoplasty skin incisions in animals.
They observed that there was no significant difference in bond strength between
the two methods at 1,2 and 4 weeks post-operatively, but the tensile strength of the
glued incisions was significantly greater than that of the sutured incisions during 9 th
post-operative week.
Samuel P.R, Roberts A.C and Nigam A (1997) various types of head and neck
operations were performed on 33 patients. All the incisions closed by using tissue
adhesive healed primarily without any infection. They also concluded that longer the
alkyl chain of adhesive molecule lesser the histotoxicity.
The effect of tissue adhesive on skin incisions in 102 patients who underwent
general and laparoscopic abdominal surgeries was studied by Qureshi A, Drew P.J,
Duthie G.S et al (1997). The study showed that N-butyl-2-cyanoacrylatetissue
adhesive can be safely and effectively used for general abdominal wound closure.
Simon H.K (1997) conducted a study to compare the long term cosmetic outcome
of N-butyl-2-cyanoacrylatewith conventional suturing for laceration repair in
children. They concluded that the N-butyl-2-cyanoacrylateis an ideal alternative to
conventional suturing for the closure of low tension lacerations with a long term
cosmetic outcome.
operative day where as more scar formation with increased local inflammation
where sutures were placed. Electron microscopic observations of both tissue
specimens revealed normal ultra-structural morphology.
Simon HK, Zempsky W.T, Burns T.B et al (1998) conducted a study to evaluate the
effects of initial wound orientation on the cosmetic outcome of facial lacerations
repaired with N-butyl-2-cyanoacrylatetissue adhesive and conventional suturing.
They concluded that initial wound orientation had a greater impact on the cosmetic
appearance for lacerations closed by suturing compared to tissue adhesive. N-
butyl-2-cyanoacrylate may be the preferred method of cutaneous closure for facial
lacerations oriented against Langer’s lines.
Osmund MH, Quinn J.V, Suteliffe T et al (1999) compared the healing and cosmetic
effects of butyl cyanoacrylate and octyl cyanoacrylate in the closure of 98 pediatric
facial lacerations. They concluded that octyl cyanoacrylate is similar to butyl
cyanoacrylate in ease of use and early and late cosmetic outcomes.
The long term effects and complications of N-butyl-2-cyanoacrylatein the closure of
1098 elective surgical incisions in pediatric patients were studied by Amiel GE,
Sukhotnik I, Kawar B et al (1999). They concluded that application of N-butyl-2-
cyanoacrylateis safe with few complications and produces excellent cosmetic
results.
produced the most consistent results, scoring higher in most of the categories when
compared with other tissue adhesives.
Rosin D, Rosenthal R.J, Kuriansky et al (2001) closed more than 250 trocar site
wounds using N-butyl-2-cyanoacrylatetissue adhesive. They found that glue
15
application is quick and easy with extremely low infection rate and provided
excellent cosmetic results. They concluded that tissue adhesive is a viable option
for laparoscopic wound closure.
Al-Belasy and Amer M.Z. (2003) studied the local hemostatic effect of N-butyl-2-
cyanoacrylate tissue adhesive in 30 warferin-treated patients who underwent
outpatient oral surgical procedures without a change in their level of
anticoagulation. They concluded that N-butyl-2-cyanoacrylatecan be used as an
effective local hemostatic agent in oral surgical procedures.
16
Chapter: two
Study population: Patients who attended the Indoor clinic of the Department of
Oral and Maxillofacial Surgery, Dhaka Dental College Hospital, Dhaka for various
surgical procedures with extra oral incision under general anaesthesia were
selected.
Sample Size: Sixty patients who attended the Department of Oral and Maxillofacial
Surgery, Dhaka Dental College Hospital, Dhaka for various surgical procedures
were selected. Among the sixty patients, thirty patients were grouped into Group-A
for application of 4/0 polypropylene suture materials and the remaining were
selected for Group-B for application of tissue adhesives
STUDY DESIGN
This study was a comparative study in between tissue adhesives and polypropylene
suture materials to observe the healing efficacy of these closure materials. Sixty
patients who attended the Department of Oral and Maxillofacial Surgery, Dhaka
18
Dental College Hospital, Dhaka for various surgical procedures were selected.
Among these patients, thirty were grouped into Group-A, for application of 4/0
polypropylene suture materials and the remaining were in Group-B for application of
tissue adhesives. The lengths of the incision were selected below the 20 c.m. in
each group. Wounds were evaluated on first and seventh post-operative day for
external bleeding, pain, wound dehiscence and wound infection. Wounds were
again reevaluated eighth post-operative week for initial scar formation and
satisfaction of the patient.
SELECTION OF CASES
Patients who were attended the Department of Oral and Maxillofacial Surgery,
Dhaka Dental College Hospital, Dhaka for various surgical procedures under
general anesthesia were selected. The selections were based on certain inclusion
and exclusion criteria:
Inclusion criteria:
The patients in good general health with no significant systemic
abnormalities.
Only clean incisions were included.
Incision with low tension following the closure of subdermal layers.
Patients from both the groups having approximately similar lengths
of incision are to be segregated for the study.
Those who will be fulfilled and consented for the study and agreed to
return for follow up are to be enrolled for the study.
Exclusion criteria:
Non-cooperative patient.
Patient who refused to attend regular follow up.
Patients with a known history of skin disease, vascular diseases
/collagen diseases and clotting disorders
Patients with a history of keloid formation and hypertrophic scars.
Patients with known history of allergy to the formaldehyde and
cyanoacrylate adhesive material are also excluded from the study.
19
A detailed clinical history for each sample was taken. Routine necessary
hematological and other investigations were done. The selected patients were
informed of procedure of surgery, method of closure of surgical wound, their
advantages and complications.
MATERIALS
Prolene commonly is used in both human and veterinary medicine for skin closure.
In human medicine it is used in cardiovascular, ophthalmic and neurological
procedures. Prolene is first manufactured by Ethicon Inc., a subsidiary of Johnson
and Johnson. The name Prolene is a trademark of Ethicon Inc.
Prolene has also become the mainstay of vascular anastomoses and had facilitated
significant advances in cardiac and vascular surgery. It is used on both small
vessels such as coronary artery bypasses and large vessels including the aorta. It
is used in obstetrical practice, during cesarean sections to suture the rectus sheath
of the abdominal wall because it is non-absorbable in nature and provides the
sheath the due strength it deserves (rectus sheath is composed of various tendon
extensions and muscle fibers and maintains the strength of the abdominal wall, if it
becomes weak the abdominal contents start herniating out) it stays there forever
and is also often seen during repeat cesarean section as that of the previous
section. A polypropylene mesh is also used for repairing hernias and other injuries
to the fascia.
20
Fig. 1.1 3D ball and stick model of polypropylene material, where carbon atoms
are represented with red ball and hydrogen atoms with blue balls.
21
N-butyl-2-cyanoacrylate
of the tissue take part. The adhesion and the elasticity decrease with the thickness
of the film of cyanoacrylate.
It became apparent after many experimental studies that the longer chain
cyanoacrylate derivatives were less toxic. Longer chains degrade at a slower rate,
thereby permitting the degradation products to be more safely metabolized and
eliciting less intense inflammatory response. The degradation products of the
polymer are Formaldehyde and Cyanoacrylate. The minimal toxicity observed with
Butyl and Iso-amyl polymer is due to low concentration of the degradation products.
Synthesis of cyanoacrylates
Fig. 1.3 Butyl-cyanoacrylate 3D-balls and stick model. Black balls representing
carbon atom, red ball representing oxygen molecule, blue balls representing
nitrogen atom and the remaining white balls representing hydrogen atom.
An adhesive has to be replaced by the body’s own tissue and should not serve as a
barrier to healing. Biodegradability is desirable as long as it is slow enough to allow
healing and the breakdown products that can be safely metabolized. The theory of
mechanism of breakdown is based on hydrolytic attack of the carbon-carbon bond
to produce Formaldehyde and resulting chain cleavage. As Butyl cyanoacrylates
have four alkyl group side chains, its biological degradation is slower than the
adhesives with shorter side chains. This slow degradation makes these materials
less histotoxic. Since they break down slowly it is not advisable to place a
24
continuous layer between two healing surfaces. The two surfaces should be
approximated and held in everted position and the adhesives are applied over the
junction.
ARMAMENTARIUM
Scale
Watch
Disposable syringes with needles.
Surgical scalpel.
Tweezers.
Scissors.
Needle holder.
Adson tissue forceps.
Straight mosquito forceps.
Dry gauges.
Straight probes.
Skin hooks.
3-0 round body Vicryl suture.
METHODS
Operational definitions:
Surgical procedure
Group A
After completing surgical procedure, careful subcutaneous closure was done with 3-
0 vicryl. Then the skin incisions were closed with 4-0 Prolene with cutting body
needle by simple interrupted suturing technique making sure that the skin edges
were in close approximation to each other during the closure. Following the
completion of suturing, an antiseptic medicated cream (Neobactin ointment) was
applied followed by a protective dressing. The length of the incision and the time
required to close the wound were recorded. The sutures removed after an interval
of 7 days.
The healing of the wound was observed on the first and seventh postoperative day
for external bleeding, pain, wound dehiscence and wound infection. The wound was
again follow up for initial scar formation and satisfaction of the patient at the eight
post-operative weeks.
26
Group B
After careful subcutaneous closure with 3-0 vicryl, the skin edges were
approximated and maintained in this position either with skin hooks, Adson forceps
or manually with fingers. The adhesive will then be applied along the edges of the
incision in thin film with insulin syringe or dropper with needle supplied with the
adhesive pack. All the time, taking care that the adhesive were not flowed between
the skin edges. It may take 5 to 30 seconds to dry but at least 5 minutes should wait
for the cyanoacrylate polymer to dry completely. The length of the incision and the
time required to close the wound was recorded. Application of any sort of
medication or associated dressing will not require since the adhesive being a water
proof, bacteriostatic and hemostatic agent acts as a private dressing. The adhesive
material need not to be removed and would fall automatically after re-
epithelialization.
The healing was observed on the first and seventh postoperative day for
external bleeding, pain, wound dehiscence and wound infection. The wound was
again follow up for initial scar formation and satisfaction of the patient at the eight
post-operative weeks.
Variable:
The following variables were considered in all subjects.
1. Length of incision
2. Wound closing time
3. External bleeding
4. Pain
5. Wound dehiscence
6. Wound infection
7. Initial scar formation
8. Satisfaction of the patient
27
Data analysis:
Data were screened and cleaned for any discrepancy. After cleaning data were
entered in to template of SPSS@17 software. Demographic and baseline
characteristics were compared with the use of chi-square test for categorical
variables and analysis of variance acceptance test for continuous variables.
Descriptive statistics were generated to see the distribution of baseline
characteristics of the patient. A two-sided p<0.05 level of significance was selected
for all analysis.
Chapter: three
Results
29
RESULTS
A total number of 60 cases were studied to compare the healing of incisions using
Prolene and N-butyl-2-cyanoacrylate in various extra oral maxillofacial surgical
procedures. This study was done to compare the healing and cosmetic outcome of
head and neck surgical incision and finally to evaluate the efficacy of n-butyl-2-
cyanoacrylate as a wound closure material in comparison to polypropylene suture.
Figure 1.4 demonstrates highest percentage (36.7%) of the total subject from both
group was from the age group 11-20 years and the lowest (5%) from the age group
over 50 years. There was no subject in Group-A (Prolene) below the age of 10
years.
Figure 1.5 demonstrates the sex distribution of the subjects. In this study among 60
patients male were 31 (51.7%) and female were 29 (48.3%).
Figure 1.6 descries the distribution of the surgical incisions in the subjects.
Submandibular (Unilateral) incisions were maximally (Total= 15, 25%) applied in
both groups followed by Preauricular (Popwitch modification) incisions (Total= 8,
13.3%) in Group-B only. Total 11 types of incisions were used in this study.
n : Number of subject
cm : Centimeter
SD : Standard Deviation
SM : Submandibular
The length (mean±SD) of the incision was 11.60±5.63 and 8.20±4.11 cm in Group-
A and Group-B respectively. The mean wound closing time for Polypropylene
material was 31.36 minute whereas the tissue adhesive needed 19.76 minutes.
Both of these parameters were statistically highly significant which were p=.010 in
Group-A and p=.000 in Group-B in unpaired t test.
in centimeters in minutes
SD : Standard Deviation
EB EB Pain Pain
1st POD (%) 1st POW (%) 1st POD (%) 1st POW (%)
EB : External Bleeding
There were no sign of wound infection in first post-operative day both in Group-A
and Group-B. Both the wound infection and wound dehiscence rate in first post-
operative week shows 13.3% and 3.30% in Group-A and Group-B respectively.
These data was not statistically significant (p=0.117) in chi-square test.
Table 3.4 Complication compare over wound infection and dehiscence (n=60)
WI WI WD WD
1st POD (%) 1st POW (%) 1st POD (%) 1st POW (%)
n : Number of incision
WI : Wound infection
WD : Wound Dehiscence
n : Number of incision
POW : Post-operative week
AA : Aesthetically Acceptable
AU : Aesthetically Unacceptable
NS : Not significant
38
Chapter: Four
Discussion
39
DISCUSSION
Early, uncomplicated wound healing has been a subject of intensive research over
the ages. The complexities involved in wound healing, such as involvement of more
than one type of tissue, various degrees of wound strength during the process of
healing, exposure of the biomaterials to body fluids and a variety of wounds, each
with its own healing problems, call for different types of wound closure materials
(Key 1995)
In general, wound closure biomaterials are divided into three major categories:
suture materials, staples and tissue adhesives. Suturing has been the most widely
used method for wound closure because of high reliability of suture materials.
However, alternative techniques have long been sought, since suturing technique
requires skill and experience, a relatively longer time and the need for its removal.
Due to these reasons, surgeons are increasingly using tissue adhesives over
sutures for wound closure (Morikawa 2001). Several studies regarding the use of
the tissue adhesives in closure of facial wounds have been conducted to compare
their efficacy against the conventional sutures (Singer 2008 and Quinn 1993).
Although most facial wounds heal without complications, owing to the abundant
blood supply of the region, mismanagement may result in infection, wound
dehiscence, and unsightly and dysfunctional scar (Toriumi 1998). Cyanoacrylate-
based adhesive systems are most recent tissue adhesives. The rapid setting time
and desirable effect of moisture on polymerization have made them most
investigated system.
To our knowledge, this is the first study that has analyzed the efficacy of N-butyl-2-
cyanoacrylate tissue adhesive as a skin closure material in different surgical
incision in maxillofacial arena in our country.
In terms of time needed to close the wound, it was persistently seen that N-butyl-2-
cyanoacrylate required less time in comparison with the Polypropylene suture. The
longer the length of the incision the greater the time difference was seen. Dalvi
(1986) conducted cyanoacrylate skin closure in 30 cases reflect this result. Quinn et
al (1993) and Toriumi et al (1998) both found the time required for closure with
cyanoacrylate adhesive was one-third of the time required for suture closure.
Pain perception in both follow-up (First and seventh post-operative day)) setting is
more or less equal in both groups. There was no significant difference in both
clinically and statistically. This result is different from Knott (2007), who found better
pain perception in cyanoacrylate group. This is may be due to the dressing applied
over some subject of cyanoacrylate group.
42
In the present study, it is noticed that there was no wound infection or dehiscence in
first post-operative day visit. However in the follow-up at 7th post-operative day N-
butyl-2-cyanoacrylate shows less (3.3%) wound infection than Prolene (13.3%).
Wound infection had been shown to be more in suture technique. Suture provides
an extra source of contamination via suture canal, perisutural cuff of dead
epidermis and subcutaneous fat. It provides all the factors necessary to initiate
wound infection.
Carpendale and Sereda (1965), in their studies, showed that wound infection is
higher with suture material as compared to use of adhesive.
Sudder Krishna (2002) used Isoamyl 2-cyanoacrylate for closing extra oral incisions
placed in maxillofacial region and reported very few cases of wound dehiscence.
He stated that wound dehiscence might be due to the pre-existing edema present
at the surgical site.
Last postoperative evaluation was done at the end of second month (8th post-
operative week) for cosmesis and satisfaction. Scar was evaluated for patient’s
acceptance and satisfaction in nominal scale. Though the study showed clinically
better acceptability and satisfaction on N-butyl-2-cyanoacrylate adhesive over
Prolene, but the difference in cosmetic outcome in between both the groups was
statistically insignificant (p=0.105 and p=0.149 respectively). Similar results were
found in several other prior studies by Quinn (1997), Toriumi (2002) and Singer et
al (2008). However a study by Bernard et al (2001) showed a statistically significant
difference in favor of sutures.
From this study it would appear that results obtained might match with the studies
of Shivmurthy et al (2009) and Dalvi et al (1986).
The present study suffered the following limitation and should be kept in mind while
deciding on the implications of the findings of the study
1. This was a single hospital based descriptive study located in the capital city
which may not be representative of the whole population.
3. Patients were not randomized with the given option to choose the method of
skin closure.
60 cases were selected for the study and divide into two equal groups. The length
of the incisions varied from 2 to 19 cm. The length of individual incision and their
closing time was recorded in each case per-operatively. These wounds were
evaluated on first and seventh day for external bleeding, pain, wound infection and
dehiscence. The cosmetic outcome was measured with initial scar formation and
satisfaction of the patient was marked at 8th post-operative week visit.
However further studies with larger sample size on our population should be
conducted to compare its performance and possible side effects before general use
can be recommended.
46
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47
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